Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: A phase II randomized trial

Figures & data

Figure 1. Study flow. DVT, deep vein thrombosis; PE, pulmonary embolism.

Table I. Characteristics of participants.

Variable (n = 10/groups)	AC	AC + AET
Age, year	46 ± 11	51 ± 6
Weight, kg	78 ± 25	78 ± 13
Body mass index, kg/m^2	28 ± 9	29 ± 5
Primary tumor size
T1, ≤ 2 cm	3 (30)	–
T2, 2–5 cm	6 (60)	5 (50)
T3 > 5 cm	1 (10)	5 (50)
Nodal status
N0	4 (40)	5 (50)
N1	5 (50)	4 (40)
N2	1 (10)	1 (10)
Tumor histology
Ductal	9 (90)	8 (80)
Lobular	1 (10)	2 (20)
Positive estrogen- and progesterone-receptor status	6 (60)	8 (80)
HER2/neu status
Positive	1 (10)	3 (30)
Negative	9 (90)	7 (70)
Exercise behavior at baseline
Total exercise, min/week median (IQR)	67.5 (0, 150)	110 (0, 260)
Exercise behavior post- intervention
Total exercise, min/week median (IQR)	90 (40, 260)	148 (60, 255)

Data presented as mean ± (SD) for continuous data and n (%) for categorical data. All comparisons, p > 0.05.

AC denotes doxorubicin and cyclophosphamide and AC+ AET denotes doxorubicin and cyclophosphamide plus aerobic exercise training.

HER2, human epidermal growth factor receptor 2.

Table 2. Efficacy of aerobic training on cardiopulmonary function.

	AC			AC ± AET			p^§
	Baseline	Follow-up	p^†	Baseline	Follow-up	p^†
Resting data (n = 10/group)
Heart rate, beats/min	74 ± 5	89 ± 9	< 0.001	75 ± 13	82 ± 12	0.209	0.124
Systolic blood pressure, mmHg	121 ± 16	116 ± 16	0.188	121 ± 9	113 ± 13	0.059	0.685
Diastolic blood pressure, mmHg	79 ± 9	75 ± 7	0.073	77 ± 7	73 ± 8	0.089	0.640
Peak exercise data (n = 10/group)
Heart rate, beats/min	157 ± 12	163 ± 15	0.039	159 ± 32	168 ± 30	0.057	0.549
Systolic blood pressure, mmHg	151 ± 17	152 ± 14	0.894	157 ± 28	161 ± 20	0.671	0.307
Diastolic blood pressure, mmHg	87 ± 5	87 ± 12	0.811	86 ± 10	84 ± 9	0.492	0.493
VO2peak, ml/kg/min	17.5 ± 4.8	16.0 ± 4.0	0.049	19.5 ± 7.6	22.1 ± 7.0	0.042	0.001
VO2peak, L/min	1.34 ± 0.32	1.20 ± 0.23	0.023	1.41 ± 0.44	1.59 ± 0.35	0.056	< 0.001
Workload, Watts	94 ± 35	87 ± 27	0.140	98 ± 42	111 ± 40	0.014	0.002
Oxygen pulse, mLO2/beat	8.5 ± 1.7	7.4 ± 1.3	0.005	9.1 ± 2.9	9.8 ± 2.8	0.233	0.005
Ventilation, L/min	51 ± 11	50 ± 12	0.955	54 ± 15	66 ± 17	0.045	0.072
RER	1.10 ± 0.09	1.12 ± 0.07	0.913	1.10 ± 0.06	1.13 ± 0.06	0.671	0.180
Echocardiography (n = 6/group)
Cardiac output, mL/min	3452 ± 469	4268 ± 1048	0.071	3467 ± 570	3566 ± 1159	0.740	0.137
Stroke volume, mL	48 ± 5	53 ± 10	0.254	47 ± 8	45 ± 10	0.614	0.219
End diastolic volume, mL	90.4 ± 12.0	96.0 ± 20.7	0.431	87.7 ± 15.7	83.7 ± 23.4	0.498	0.336
End systolic volume, mL	43.0 ± 6.7	43.4 ± 13.3	0.919	40.7 ± 12.2	38.6 ± 14.7	0.691	0.688
LVEF, %	53 ± 2	55 ± 6	0.364	54 ± 9	55 ± 6	0.589	0.887

Data presented as mean ± SD.

AC denotes doxorubicin and cyclophosphamide and AC + AET denotes doxorubicin and cyclophosphamide plus aerobic exercise training.

LVEF, left ventricular ejection fraction; RER, respiratory exchange ratio; VO_2peak, peak oxygen consumption; V_E, ventilation.

†Paired t-test p-value for change within group from baseline to 12 weeks; §p-value for change between groups from baseline to 12 weeks based upon analysis of covariance adjusted for baseline value.

Table III. Efficacy of aerobic training on patient-reported outcomes.

Variable (n = 10/group)	AC			AC + AET			p^§
	Baseline	Follow-up	p^†	Baseline	Follow-up	p^†
FACT-B Total (Scale: 0–144)	112.4 ± 5.9	110.9 ± 7.6	0.592	94.6 ± 22.8	105.7 ± 21.3	0.145	0.685
FACT-G Total (Scale: 0–108)	86.9 ± 5.6	85.9 ± 6.2	0.383	71.2 ± 15.7	80.2 ± 16.7	0.088	0.431
PWB (Scale: 0–28)	24.6 ± 4.0	21.2 ± 3.8	0.001	20.6 ± 5.9	20.7 ± 7.2	0.972	0.485
SWB (Scale: 0–28)	24.7 ± 1.6	25.2 ± 2.3	0.541	18.3 ± 4.8	21.8 ± 2.3	0.033	0.139
EWB (Scale: 0–24)	18.6 ± 3.1	20.1 ± 2.0	0.043	15.9 ± 4.7	19.1 ± 5.3	0.043	0.618
FWB (Scale: 0–28)	19.1 ± 2.9	19.4 ± 3.4	0.814	16.4 ± 5.3	18.6 ± 4.7	0.187	0.849
FACIT-Fatigue (Scale: 52)	44.4 ± 6.0	42.2 ± 3.4	0.254	35.3 ± 13.4	32.8 ± 14.8	0.583	0.327

Data presented as mean ± SD.

AC denotes doxorubicin and cyclophosphamide and AC + AET denotes doxorubicin and cyclophosphamide plus aerobic exercise training.

EWB, emotional well-being; FACT-B, Functional Assessment of Cancer Therapy-Breast; FACT-G, Functional Assessment of Cancer Therapy-General; FACIT, Functional Assessment Chronic Illness Therapy; FWB, functional well-being; PWB, physical well-being; SWB, social well-being.

†Paired t-test p-value for change within group from baseline to 12 weeks; §p-value for change between groups from baseline to 12 weeks based upon analysis of covariance adjusted for baseline value.